ISO 13485 is an international standard that serves as a model for medical device manufacturers to meet regulatory requirements. It includes particular requirements for medical devices and excludes some requirements in ISO 9001 that are not applicable. This standard applies for organisations that design, develop and produce medical devices.
The ISO 13485:2016 is now applicable for organisations operating in:
- storage and distribution of medical devices
- medical equipment installation
- servicing of medical devices
- final decommissioning and disposal of medical devices
- design and development of medical equipment
- provision of associated activities (e.g. technical support)
Additionally, the international standard applies to suppliers or external parties providing the products (e.g. raw materials, devices, sterilisation services, calibration maintenance services) to such organisations.
ISO 13485 Quality Management System (QMS) for Medical Devices is recognised and supported
Regulators, including the Medical Devices Authority (MDA), Ministry of Health have adopted this standard with the aim of:
- harmonising the quality of system requirements
- reduce conflicts of different standards
- facilitate licence application for medical devices manufacturers
The Medical Devices Authority (MDA) referred to ISO 13485 in implementing the Medical Devices Act 2012 (Act 737).
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